clobetasol propionate
- Product NDC
- 21695-201
- 11-digit product format
- 216950201
- Labeler code
- 21695
- Product ID
- 21695-201_df79a35c-ce5c-452e-b81e-50a014fc94f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clobetasol propionate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA074392
- Marketing category
- ANDA
- Marketing start
- 1996-09-30
- Marketing end
- 0000-00-00
- Substance
- CLOBETASOL PROPIONATE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 20abe2c3-3e80-d2b2-39eb-3156e4af4799 | Product name | 3 | 20250124 |
| 45ad92f8-d116-4c0c-851c-2e740b7d8e6f | Product name | 1 | 20250122 |
| 42be0ad5-6fd7-4f1b-8108-6d9dd7d571df | Product name | 7 | 20250107 |
| 3813b789-94b9-edd6-f010-6b926dd462e5 | Product name | 5 | 20230113 |
| 30eee8a1-850e-41ed-b5ab-761301aeab49 | Product name | 6 | 20221206 |
| 18e5b6f7-c414-b1f1-b684-17fdd02c215e | Product name | 4 | 20210927 |
| 1c87bbde-dd91-a122-db33-67ae814cb645 | Product name | 7 | 20210510 |
| 519b5875-7d7d-4aa6-9d3d-470fa1376595 | Product name | 4 | 20200227 |
| 98669154-3e9c-47da-8a2c-656ab71848be | Product name | 2 | 20180607 |
| 8d4f8539-436f-453b-8b76-5322d403fc8e | Product name | 1 | 20180131 |
| 837ac3c6-ee71-c5a6-6eba-c4065f37e9f5 | Product name | 2 | 20171010 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-201-15 | 2019-09-24 | C162847 | 48780-1 | 934fe258-49e3-48b1-e053-8cdaa90a720a | CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate) |
| 21695-201-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-49e3-48b1-e053-8cdaa90a720a | CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-201-15 | clobetasol propionate | 15 g in 1 TUBE | CREAM | 15 | 1 | |
| 21695-201-60 | clobetasol propionate | 60 g in 1 TUBE | CREAM | 60 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 861495 | clobetasol propionate 0.05 % Topical Cream | PSN | df79a35c-ce5c-452e-b81e-50a014fc94f4 | 1 |
| 861448 | clobetasol propionate 0.05 % Topical Ointment | PSN | df79a35c-ce5c-452e-b81e-50a014fc94f4 | 1 |
| 861448 | clobetasol propionate 0.0005 MG/MG Topical Ointment | SCD | df79a35c-ce5c-452e-b81e-50a014fc94f4 | 1 |
| 861495 | clobetasol propionate 0.5 MG/ML Topical Cream | SCD | df79a35c-ce5c-452e-b81e-50a014fc94f4 | 1 |
| 861495 | clobetasol propionate 0.05 % Topical Cream | SY | df79a35c-ce5c-452e-b81e-50a014fc94f4 | 1 |
| 861448 | clobetasol propionate 0.05 % Topical Ointment | SY | df79a35c-ce5c-452e-b81e-50a014fc94f4 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-201-15 | 21695020115 | 15 g in 1 TUBE | 15 g | Historical |
| 21695-201-60 | 21695020160 | 60 g in 1 TUBE | 60 g | Historical |